CORE--CLINICAL COMPONENT

核心——临床部分

• 批准号: 6797508
• 负责人: GUADALUPE GARCIA-TSAO
• 金额: $ 18.76万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6797508
• 关键词: biomedical facility; biomedical registry /referral center; clinical trials; data management; information systems; medical outreach /case finding; patient /disease registry; statistical service /center; statistics /biometry

Providing a resource (Clinical Study Coordinator) with particular expertise in effectively addressing NIH, IRB and HIPAA policies and reporting requirements concerning confidentiality, inclusion of women, children and ethnic/minority participation in clinical studies, data and safety monitoring requirements; and educational requirements for the protection of human research participants. As recognized recently, perhaps the least appreciated (but most important) barrier to translational and clinical research is the limited availability of administrative support for translation at most academic medical Centers [1; 2]. With the increasing regulatory requirements for translational and clinical research, worthwhile studies are currently being abandoned simply because of the burden of regulatory compliance [1]. The main objective of the clinical component of the Yale Liver Center is to alleviate this regulatory burden by providing this resource. This resource is of particular importance for Yale investigators since patients for clinical trials are recruited from both Yale-New Haven Medical Center and from the CT-VA Healthcare System, and each of them have separate IRBs and separate regulatory requirements. Additionally, this resource will maintain a patient, serum and DNA data and aid in the identification (through the clinical and sample databases) and recruitment of subjects for translational and clinical studies. This resource will constitute a bridge between Center basic science investigators and clinical investigators and among clinical investigators. b) Providing a resource (Biostatistician) that provides assistance to basic researchers with clinical study design, particularly for small pilot projects that are the initial step in the translational process. For established clinical investigators using the clinical component, this resource will provide consultation for clinical study/trial development particularly in establishing sample size calculations and advise regarding the most appropriate study design. c) Providing the opportunity for Center members to obtain patient data and clinical (serum, liver, DNA) samples needed for their research, including data regarding the number of patients available to evaluate study feasibility and estimated times for patient recruitment into clinical trials. This service will be provided through the Patient Database and the Serum, Liver Biopsy and DNA banks that will be maintained by the Clinical Study Coordinator.

在有效解决NIH，IRB和HIPAA政策以及有关机密性，妇女，儿童纳入妇女，儿童以及少数民族参与临床研究，数据和安全监测要求方面的报告要求方面，提供有效解决NIH，IRB和HIPAA政策的特殊专业知识；以及保护人类研究参与者的教育要求。正如最近认可的那样，转化和临床研究的最不受欢迎（但最重要的）障碍是在大多数学术医疗中心对翻译的行政支持有限[1; 2]。随着对翻译和临床研究的监管要求的日益增加，仅仅是因为法规依从性的负担，目前正在放弃有价值的研究[1]。耶鲁肝中心临床成分的主要目标是通过提供此资源来减轻这种监管负担。对于耶鲁大学的调查人员而言，此资源尤其重要，因为从耶鲁大学新避风港医疗中心和CT-VA医疗保健系统中招募了临床试验的患者，并且每个人都有单独的IRB和单独的法规要求。 此外，该资源将维持患者，血清和DNA数据并有助于识别 （通过临床和样本数据库）以及招募转化和临床研究的受试者。该资源将构成中心基础科学研究者与临床研究人员以及临床研究人员之间的桥梁。 b）提供一种资源（生物统计学家），该资源为具有临床研究设计的基础研究人员提供帮助，特别是对于小型试点项目，这是转化过程中的第一步。对于既定的临床研究人员，使用临床组件，该资源将为临床研究/试验开发提供咨询，尤其是在建立样本量计算和有关最合适的研究设计的建议方面。 c）为中心成员提供了获取其研究所需的患者数据和临床（血清，肝脏，DNA）样本的机会，包括有关可评估研究可行性的患者数量以及患者招募临床试验的估计时间的数据。该服务将通过患者数据库以及将由临床研究协调员维护的血清，肝活检和DNA库提供。